Paris, France – Shanghai MicroPort Medical (Group) Co ("MicroPort®") recently attended EuroPCR 2016, a world leading course in interventional cardiovascular medicine that was held in Paris, to promote our Firesorb™ Bioresorbable Rapamycin Target Eluting Coronary Scaffold System ("Firesorb™") and Firehawk® Rapamycin Target Eluting Coronary Stent System ("Firehawk®"), and released the latest developments of Firesorb™ FUTURE Series Clinical Trial and Firehawk® studies.
Firesorb™ Clinical Trial: FUTURE-I Completes Patient Enrollment, FUTURE-II Officially Launched
Hosted by the European Association for Percutaneous Cardiovascular Interventions ("EAPCI"), EuroPCR 2016 attracted more than 12,000 interventional cardiologists, nurse, technicians, scientists and industry innovators from around the world. On May 19, Dr. Qiyi Luo, Chief Technology Officer of MicroPort®, shared the R&D technology of the second-generation fully bioresorbable scaffold Firesorb™, as well as the patient enrollment developments and the primary endpoint of its FUTURE-I and FUTURE-II Clinical Trials.
In-house developed by MicroPort®, Firesorb™ adopts the same abluminal coating technology as Firehawk®. Its wall thickness is only 100μm-125μm, better than other competitive products, and the thinner strut could lower the crossing profile, shorten the bio-degradation time, so as to reduce the risk of postoperative thrombosis. In Firesorb™'s target sirolimus-eluting design, the drug only retains on one surface that contacts blood vessels, with 60% less drug loadings compared to similar products. Such design reduces the dose of drug, enhances the efficiency of the treatment, and prevents a large amount of drug residual from remaining in the body for a long time, while achieving the same clinical efficacy as other bioresorbable scaffolds. In addition, testing finds that there is no significant difference in radial strength between Firesorb™ and metal stents.
Currently, MicroPort® has completed the patient enrollment for the perspective, single group observation, First-in-Man ("FIM") FUTURE-I Clinical Trial of evaluating the safety and efficacy of Firesorb™ in the treatment of coronary heart diseases, and a total of 45 patients were enrolled in the trial. The clinical trial has gone smoothly and has provided the first evidence of Firesorb™'s safety and efficacy. According to the design of the clinical trial, clinical follow-up will be performed in the 45 patients in one month, 6 months, one year, two years, three years, four years and five years after scaffold implantation.
Meanwhile, the Firesorb™'s Randomized Controlled Trial FUTURE-II has been launched, which will be carried out in 20 centers with 610 enrolled patients. The study will include two cohorts: cohort 1 and 2. All patients will be randomized to Firesorb™ or CoCr-EES stents in a 1:1 ratio. The primary endpoint of the study will be the in-segment late loss at 12 months (noninferiority) in Cohort 1. Powered Major Secondary Endpoints of the study includes: Proportion of device strut coverage at 12 months (sequential noninferiority and superiority) by OCT in Cohort 1; Vasomotion defined as the change in mean lumen diameter between pre- and post-nitrate at 2.5 years (superiority) in Cohort 2; Cumulative incidence of angina assessed by Patient Reported Outcome form through 12 months (with exclusion of 0-7 days) after index procedure (superiority) in Cohort 1 + 2.
According to Dr. Luo, with the launch of the FUTURE Series Clinical Trials, MicroPort® will further refine the design of Firesorb™ in the future, to provide better solutions with the bioresorbable scaffold to China and the world.
Firehawk® Surgeries Live Broadcasted & New Developments in Firehawk® Studies Released
On May 20, three operations in which Firehawk® was used were live broadcasted in EuroPCR 2016. Among them, two were conducted by Fuwai Hospital of Chinese Academy of Medical Science for the treatment of complex left main coronary artery disease. Professor Shubin Qiao and Professor Yuejin Yang, the main performers of the two operations, used TAP-stenting technique and single-stent technique respectively to implant four Firehawk®, with skilled technique and precise diagnose. The operations achieved successful results according to IVUS findings, and were well received by attendees. In another operation live broadcasted, Professor Christoph K. Naber of the German hospital Essen successfully placed a Firehawk® in the lesion with rotational atherectomy.
Meanwhile, an investigator meeting on TARGET All Comer ("TARGET AC"), a large-scale clinical trial of Firehawk® in Europe, was held during EuroPCR 2016. Investigators from 10 European countries that participated in the trial and members of the project executive committee attended the meeting. Four well-known cardiovascular experts were invited to elaborate the clinical trials of Firehawk® from various angles. US renowned pathologist Dr. Renu Virmani introduced the solid fundamental researches of Firehawk®. Professor William Wijns of the Cardiovascular Center in Aalst of Belgium, who is the president of EuroPCR, shared the innovative design and updates of the TARGET AC clinical trial. Professor Andreas Baumbach of Bristol Heart Institute in the UK and Professor Henning Kelbӕk from Denmark respectively explained five cases recruited in their centers with the attendees. On behalf of the Firehawk® TARGET II study team, Professor Hesong Zeng of Tongji Medical College of Huazhong University of Science and Technology released the one-year and three-year follow-up data regarding the sub-study of the 33mm and 38mm long stents. TARGET Series studies are clinical trials of Firehawk® that take place in China, launched before TARGET AC clinical trial. The attendees spoke highly of the excellent performance of Firehawk® in TARGET II study, and are looking forward to the completion of patient enrollment for TARGET AC, the endpoint of the trial, and the outcome of its sub-study.
Dr. Patrick Serruys, Professor of Interventional Cardiology at the Thoraxcenter of the Erasmus MC, pointed out during the EuroPCR 2016, that the advancement in R&D of Asian interventional devices has deeply impacted the US and European markets, and Asia may lead the industry in medical device innovations in the future. As a leading high-end medical device provider in China and Asia, MicroPort® will constantly strive for innovations, to provide better medical solutions to China and the world and benefit more patients with coronary heart diseases.